EP0248632B1 - Moniteur pour l'administration de fluides intraveineux - Google Patents

Moniteur pour l'administration de fluides intraveineux Download PDF

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Publication number
EP0248632B1
EP0248632B1 EP19870304858 EP87304858A EP0248632B1 EP 0248632 B1 EP0248632 B1 EP 0248632B1 EP 19870304858 EP19870304858 EP 19870304858 EP 87304858 A EP87304858 A EP 87304858A EP 0248632 B1 EP0248632 B1 EP 0248632B1
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EP
European Patent Office
Prior art keywords
pressure
fluid
delivery system
flow rate
flow
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Expired
Application number
EP19870304858
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German (de)
English (en)
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EP0248632A3 (en
EP0248632A2 (fr
Inventor
James H. Philip
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Ivac Medical Systems Inc
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Ivac Medical Systems Inc
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Application filed by Ivac Medical Systems Inc filed Critical Ivac Medical Systems Inc
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Publication of EP0248632A3 publication Critical patent/EP0248632A3/en
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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/14—Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
    • A61M5/168—Means for controlling media flow to the body or for metering media to the body, e.g. drip meters, counters ; Monitoring media flow to the body
    • A61M5/16831—Monitoring, detecting, signalling or eliminating infusion flow anomalies
    • A61M5/16854—Monitoring, detecting, signalling or eliminating infusion flow anomalies by monitoring line pressure
    • A61M5/16859—Evaluation of pressure response, e.g. to an applied pulse

Definitions

  • This invention relates to an apparatus for monitoring the flow of intravenous fluid through a parenteral fluid delivery system into a patient's vein. More particularly, the invention relates to apparatus and methods for detecting on a real time basis whether such a fluid is flowing successfully into the patient's vein, whether it is infiltrating the soft tissue surrounding the vein, whether the vein is occluded, whether the vein is phlebitic or whether the cannula has been detached completely from the patient's vein, or if any other disconnection has occurred.
  • parenteral fluids to the blood streams of patients by means of cannulas inserted into the veins has been conventional for many years. More recently, parenteral systems have been introduced in which the fluids are positively pumped into the patient's veins, as opposed to earlier systems in which gravity was the motivating force. Pumping has become prevalent because it permits more precise control of fluid flow. Still more recently, systems have been developed in which the pressure in the line connecting the pump to the vein is monitored and a pressure signal is transmitted to a microprocessor or similar device for continuous monitoring of the pressure, so as to determine whether the pressure is within certain limits indicative of proper fluid flow. The goal of such instruments is to provide an indication of whether the cannula is properly in the vein, whether the vein flow is normal, and so on.
  • the art requires an improved intravenous flow monitor which is capable of distinguishing between actual problems, e.g. occlusion of the vein, a cannula becoming detached from the patient's arm, or penetrating through or being withdrawn from the vein so as to be disposed in the surrounding soft tissue, and between artifacts such as relative changes in elevation of the pump and the point of injection of the fluid into the patient.
  • actual problems e.g. occlusion of the vein, a cannula becoming detached from the patient's arm, or penetrating through or being withdrawn from the vein so as to be disposed in the surrounding soft tissue
  • artifacts such as relative changes in elevation of the pump and the point of injection of the fluid into the patient.
  • the present inventor has realized that what is needed is an actual measurement of the resistance to flow characteristic of the tissue into which the fluid is being injected. To provide such an indication of resistance to flow provides accurate flow monitoring, regardless of the absolute pressure in the line.
  • an object of the invention to provide an intravenous flow monitor which provides an actual indication of the resistance to flow at the point of insertion of the cannula.
  • the present inventor has realized further that, given an actual measurement of the resistance to flow, one can then further determine the location of the cannula.
  • the resistance to flow of a phlebitic or occluded vein can be differentiated from the resistance to flow of a normal vein.
  • infiltration a condition referred to as "infiltration"
  • infiltration is a serious condition which can lead to injury.
  • a measure of the resistance to flow can readily provide an indication that the catheter has become disconnected.
  • an object of the invention to provide an improved intravenous flow monitor which provides a measure of the resistance to flow of fluid in the line connecting the source of fluid and the cannula, and which furthermore uses such measurement to provide an indication of the conditions at the end of the cannula, i.e. occluded vein, healthy vein, phlebitic vein, disconnection, infiltration, and so forth.
  • the present invention meets the needs of the art and objects of the invention discussed above by its provision of an improved intravenous pressure monitor in which a peristalitic or other pump is controlled by a microprocessor or an equivalent device to increase and decrease the flow rate, and in which the change in pressure in the fluid line connecting the pump and the patient responsive thereto is monitored.
  • the ratio of the change in pressure to the change in fluid flow rate is the "dynamic resistance" in the line, this term being used to refer to the resistance sensed with respect to a perturbation in flow rate which is small compared to the flow rate and a responsive perturbation in pressure. If resistance is taken to be equal to the thus-computed dynamic resistance, by comparing the resistance in the line to values predetermined by experiment, one can determine the conditions at the cannula. Thus, for example, if the cannula has become detached completely from the patient, there will be substantially no resistance and the pressure will change very little with change in the flow rate. On the other hand, if the cannula has entered an occluded vein, typically the pressure will change significantly with changes in flow rate.
  • the microprocessor also monitors the rise time of changes in the pressure; for example, if a square wave change is provided in the flow rate, the corresponding change in the pressure will be somewhat rounded. By monitoring the extent of this rounding, one can differentiate between certain other conditions.
  • the resistance to flow of phlebitic vein in some cases can be substantially equal to the resistance to flow of the soft tissue typically surrounding veins, such that a phlebitic vein could not be distinguished from infiltration merely by monitoring the resistance to flow.
  • the rise time of the pressure changes resulting from square-edged changes in the rate can be used to differentiate between these two conditions.
  • the system embodying features of the invention generally comprises a fluid supply 10 of any desired parenteral fluid and a pump 12, which may typically be a peristaltic pump to which is connected a tube 14 which in turn is connected to a cannula 16 inserted into the vein of a patient.
  • the pressure in the line 14 is monitored by a pressure transducer 18 which is connected to an analog-to-digital converter 20 for supplying digital data representing the pressure in the tube 14 to a microprocessor 22.
  • the microprocessor 22 provides output signals to a flow rate controller 24 which controls the rate of flow delivered by the pump 12.
  • the microprocessor 22 also provides an operator display 26 and can generate an alarm signal at 28 when certain conditions discussed in detail below are detected.
  • the microprocessor 22 is also enabled to accept operator input for controlling the rate of flow and the like.
  • the fluid flow rate is sequentially varied and the difference in pressure caused by the variations in flow rate is noted.
  • the instrument can determine the dynamic resistance to flow in the line, which is in turn a measure of the resistance to flow in the environment at the end of the catheter, e.g. in a patient's vein, the tissue surrounding the vein, or the like.
  • Figure 2 shows a graph of pressure P versus flow rate F and indicates how measurement of the dynamic resistance can be derived.
  • the operator will have set the initial flow rate at some value F s .
  • a corresponding value for the pressure P s is detected by the pressure transducer 18.
  • the microprocessor then sequentially varies the flow rate F about F s in one or both directions.
  • the pressure transducer detects corresponding variations in the pressure P as indicated on Figure 2. Two or more points indicating corresponding values for the flow rate and pressure can then be connected, and the slope of the resulting line is equivalent to the dynamic resistance to flow at the end of the cannula.
  • this "dynamic resistance,” as it is termed herein, is not a measurement of the absolute resistance to flow, because no absolute pressure measurement is made.
  • the measurement in effect is of the variation in resistance to fluid flow variation.
  • resistance is used in the claims of this application, and should be so understood. The inventor herein has found that a clinically useful measurement is provided.
  • Figure 3 comprises Figures 3A and 3B, which show typical input fluid flow rate changes and typical detected changes in pressure, respectively.
  • the first condition represented by the initial change, is for a normal vein; in response to the square edged change in the flow rate, the pressure changes correspondingly.
  • the change appearing in the pressure waveform is somewhat rounded, having a "rise time" T. This is due to compliance in the lines connecting the pump and the vein, as well as compliance of the normal vein itself.
  • the second case shown is that of an occlusion in the vein or the connecting tubing.
  • There the change in the flow rate is responded to by a very high change in the pressure, due to the blockage of the occluded vein or tubing.
  • the third case shown is of an infiltrated vein, that is, one which the cannula has actually penetrated through the vein and is in the soft tissue surrounding the vein.
  • the pressure rises substantially, but over a period of time T as the parenteral fluid is pumped into the soft tissue.
  • T the pressure rises substantially, but over a period of time T as the parenteral fluid is pumped into the soft tissue.
  • this can be a serious condition leading at least to local or more generalized tissue damage.
  • the fourth condition shown is that of a phlebitic vein, in which the vein tends to be stiffer than usual, as well as possibly having some constriction therein.
  • the pressure rise is comparable to that shown in the infiltrated case, but occurs much more quickly, due to the stiffness of the vein. Measurement therefore of the rise time T can provide a way of differentiating between these two conditions, as discussed below in connection with Figure 4.
  • Figure 4 shows a plot of actual data, showing the relationship of the absolute value of the dynamic resistance of the vein R, in torr * hr/ml versus the rise time of the pulse T; a number of areas are delineated on the chart to indicate experimental variation and the like.
  • a disconnected cannula produces very low resistance; a normal vein shows a somewhat higher range of resistance; a phlebitic vein is higher still; and an occluded vein is highest of all.
  • an infiltration condition gives a value for resistance to flow which is more or less equivalent to that of a phlebitic vein, but has a much higher rise time T.
  • FIG. 5 shows the flow chart according to which the microprocessor performs these operations.
  • Processing begins at step 40.
  • the first step 42 is to increase the flow rate and to record a change in flow rate ⁇ F, a change in pressure ⁇ P and the rise time T.
  • ⁇ P is compared to certain preset limits. This is because flow rates can vary quite widely, between on the order of millitiers per hour to liters per hour. Accordingly, to simply vary the flow rate by some fixed amount might not always yield a statistically significant change ⁇ P in the line pressure. Similarly, it may cause non-physiologic extreme changes in pressure. Accordingly, ⁇ P is compared to preset limits.
  • the flow rate change ⁇ F is altered at step 46 and the process is reperformed. This may be done by the microprocessor automatically, by the operator, or by an interactive combination of both.
  • the same procedure is performed by decreasing the flow at step 48 and again recording ⁇ F, ⁇ P and T.
  • the slope of the line connecting the corresponding values for P and F is calculated. The slope of this line is the resistance R.
  • the resistance is compared to preset levels established by experimentation. If the resistance value is ambiguous, as tested at step 54, then the rise time value T is evaluated at step 56. After resolution, if needed, the corresponding output signal is generated at step 58, e.g., on the display 26 ( Figure 1).
  • the rise time T can be simply calculated by programming the microprocessor 22 to take the time derivative of the pressure signal, which would typically be sampled at regular intervals, e.g. every 10 msec. When the derivative is within some predetermined distance from zero, indicating that the pressure pulse has substantially reached its peak, this can be taken as the cut-off point, so that the time between the sending of the flow rate pulse signal to the flow rate controller 24 ( Figure 1) and this point is the rise time T.
  • Other well known rise time measurement techniques e.g., mean transit time measurement techniques are with the skill of the art.
  • a further improvement can be made by increasing the sophistication of the signal processing system, e.g., by performing a Fourier analysis in order to determine the information directly relevant to the system's impedance to flow over a spectrum of frequencies.
  • Sinusiodal and white noise variation may be used, a indicated by step 48a of Figure 5, which substitutes for step 48 according to this alternative embodiment.
  • Steps 50a-56a show the remaining processing steps in this alternative embodiment.
  • step 50a the pressure in the line is monitored as a function of the change in flow rate.
  • the Fourier transform is taken of this data; the result is the actual impedance to flow of the tissues at the end of the catheter.
  • the impedance thus determined is compared to experimentally determined values, and at step 56a the corresponding condition is displayed.

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  • Health & Medical Sciences (AREA)
  • Vascular Medicine (AREA)
  • Engineering & Computer Science (AREA)
  • Anesthesiology (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Hematology (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Infusion, Injection, And Reservoir Apparatuses (AREA)

Claims (25)

  1. Système pour surveiller l'administration d'un fluide parentéral par un système d'administration d'un fluide (14) à un patient, comprenant
    (a) des moyens (10, 12) pour administrer le fluide parentéral selon un débit contrôlable par la système d'administration de fluide à un patient; et
    (b) des moyens (18) pour surveiller la pression du fluide dans le système d'administration de fluide qui administre le fluide parentéral à un patient; caractérisé par
    (c) des moyens (24) pour faire varier le débit du fluide d'une manière prédéterminée;
    (d) des moyens pour déterminer, à partir des variations du débit et en conjonction avec les variations correspondantes de la pression du fluide dans le système d'administration de fluide, la résistance à l'écoulement, telle qu'elle est définie ici, dans le système d'administration de fluide; et
    (e) des moyens (22) pour comparer la résistance avec des limites prédéterminées et pour générer des signaux de sortie sensibles à ces derniers.
  2. Système selon la revendication 1, dans lequel les moyens pour calculer la résistance dans le système d'administration de fluide et les moyens pour comparer la résistance à des limites prédéterminées sont constitués par un micro-ordinateur.
  3. Système selon la revendication 2, dans lequel le microordinateur comprend dos moyens pour surveiller la vitesse de modification de la pression dans le système d'administration de fluide qui sont sensibles à des modifications du débit du fluide.
  4. Système selon la revendication 3, dans lequel le microordinateur analyse la modification dans le temps de la pression dans le système d'administration de fluide et calcule la durée de transit moyenne des modifications pulsatives du débit du fluide.
  5. Système selon la revendication 3, dans lequel le microordinateur analyse la vitesse de modification de la pression dans le système d'administration de fluide et calcule une constante de temps pour les modifications de la pression qui est sensible aux modifications du débit dans le système d'administration de fluide.
  6. Système selon la revendication 1 ou 2, dans lequel les moyens pour surveiller la pression dans le système d'administration de fluide sont constitués par un transducteur de pression émettant en sortie un signal analogique, et le système comprend en outre des moyens convertisseurs analogiques/numériques pour la conversion du signal analogique en un signal numérique qui est appliqué au micro-ordinateur.
  7. Système selon la revendication 2, dans lequel le micro-ordinateur détermine les modifications de la pression par rapport aux modifications du débit, pour déterminer une valeur de résistance.
  8. Système selon la revendication 7, dans lequel le micro-ordinateur comprend en outre des moyens pour surveiller la vitesse de modification de la pression.
  9. Système selon la revendication 1, dans lequel la résistance à l'écoulement est une impédance.
  10. Système selon la revendication 2, dans lequel le micro-ordinateur comprend en outre des moyens pour surveiller l'impédance qui sont sensibles aux variations du débit, les variations ayant un spectre de fréquences prédéterminé.
  11. Système selon la revendication 10, dans lequel le micro-ordinateur comprend des moyens pour établir la transformation de fourier des variations de la pression qui sont sensibles aux variations du débit.
  12. Système selon la revendication 10, dans lequel ledit micro-ordinateur comprend en outre des moyens calculer la dérivée par rapport au temps des modifications de la pression.
  13. Système selon la revendication 9, dans lequel les moyens pour administrer le fluide parentéral selon des débits contrôlables comprennent des moyens pour provoquer une variation des débits d'une manière comportant une composante de fréquence définie, et dans lequel les moyens pour déterminer l'impédance à l'écoulement comprennent des moyens pour analyser les variations de la pression qui sont sensibles aux variations des débits.
  14. Procédé pour surveiller l'administration d'un fluide parentéral par un système d'administration de fluide à un patient, comprenant
    (a) l'administration de fluide parentéral selon un débit contrôlable par le système d'administration de fluide à un patient; et
    (b) la surveillance de la pression du fluide dans le système d'administration de fluide qui administre le fluide parentéral à un patient, caractérisé par:
    (c) la modification du débit du fluide selon une manière prédéterminée;
    (d) la détermination, à partir des variations du débit en conjonction avec les variations correspondantes de la pression du fluide dans la système d'administration de la résistance à l'écoulement, telle qu'elle est définie dans le système d'administration de fluide; et
    (e) la comparaison entre la résistance et des limites prédéterminées et la génération de signaux de sortie sensibles à ces dernières.
  15. Procédé selon la revendication 14, dans lequel est surveillée la vitesse de modification de la pression dans le système d'administration de fluide qui est sensible aux modifications du débit du fluide.
  16. Procédé selon la revendication 15, dans lequel est analysée la vitesse de modification de la pression dans le système d'administration de fluide et est calculée la durée moyenne de transit des modifications pulsatives du débit du fluide.
  17. Procédé selon la revendication 15, dans lequel est analysée la vitesse de modification de la pression dans le système d'administration de fluide et est calculée une constante de temps pour les modifications de la pression qui est sensible aux modifications du débit dans le système d'administration de fluide.
  18. Procédé selon la revendication 15, dans lequel la pression dans le système d'administration de fluide est surveillée par un transducteur de pression émettant un signal analogique, et le procédé comprend en outre la conversion du signal analogique en un signal numérique.
  19. Procédé selon la revendication 15, dans lequel les modifications de la pression par rapport aux modifications du débit sont déterminées de manière à déterminer une valeur de résistance.
  20. Procédé selon la revendication 19, dans lequel la vitesse de modification de la pression est surveillée.
  21. Procédé selon la revendication 14, dans lequel la résistance calculée est une valeur d'impédance.
  22. Procédé selon la revendication 21, dans lequel la réponse de l'impédance à des variations des débits est surveillée, les variations ayant un spectre de fréquences prédéterminé.
  23. Procédé selon la revendication 22, comprenant la détermination des transformées de Fourier des variations de la pression qui sont sensibles aux variations du débit.
  24. Procédé selon la revendication 22, dans lequel est calculée la dérivée par rapport au temps des modifications de la pression.
  25. Procédé selon la revendication 22, dans lequel le fluide parentéral est administré selon des débits contrôlables qui sont modifiés d'une manière présentant une teneur en fréquence définie, et l'impédance à l'écoulement est déterminée par l'analyse des variations de la pression qui sont sensibles aux variations des débits.
EP19870304858 1986-06-06 1987-06-02 Moniteur pour l'administration de fluides intraveineux Expired EP0248632B1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US87219986A 1986-06-06 1986-06-06
US872199 1986-06-06

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EP0248632A2 EP0248632A2 (fr) 1987-12-09
EP0248632A3 EP0248632A3 (en) 1989-03-15
EP0248632B1 true EP0248632B1 (fr) 1992-04-15

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EP19870304858 Expired EP0248632B1 (fr) 1986-06-06 1987-06-02 Moniteur pour l'administration de fluides intraveineux

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EP (1) EP0248632B1 (fr)
JP (1) JP2553557B2 (fr)
CA (1) CA1279800C (fr)
DE (1) DE3778211D1 (fr)

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Also Published As

Publication number Publication date
EP0248632A3 (en) 1989-03-15
JP2553557B2 (ja) 1996-11-13
DE3778211D1 (de) 1992-05-21
EP0248632A2 (fr) 1987-12-09
JPS6365876A (ja) 1988-03-24
CA1279800C (fr) 1991-02-05

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